duct Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0468
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEFERASIROX (DEFERASIROX) DEFERASIROX 125mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE K30
SILICON DIOXIDE
SODIUM LAURYL SULFATE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 12mm
Flavor Imprint Code J;125;NVR
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0468-15 30 TABLET, FOR SUSPENSION (30 TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021882 11/30/2005
EXJADE
deferasirox tablet, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0469
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEFERASIROX (DEFERASIROX) DEFERASIROX 250mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE K30
SILICON DIOXIDE
SODIUM LAURYL SULFATE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 15mm
Flavor Imprint Code J;250;NVR
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0469-15 30 TABLET, FOR SUSPENSION (30 TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021882 11/30/2005
EXJADE
deferasirox tablet, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0470
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEFERASIROX (DEFERASIROX) DEFERASIROX 500mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE K30
SILICON DIOXIDE
SODIUM LAURYL SULFATE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 20mm
Flavor Imprint Code J;500;NVR
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0470-15 30 TABLET, FOR SUSPENSION (30 TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021882 11/30/2005
Labeler -Novartis Pharmaceuticals Corporation (002147023)
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